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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

What Glomox is: Glomox is an antibiotic. It contains a medicine called amoxicillin as the active ingredient which belongs to a class of antibiotics called ‘penicillins’.

What Glomox is used for: Glomox is used to treat infections caused by bacteria in different parts of the body. Glomox may also be used in combination with other medicines to treat stomach ulcers.


Do not take Glomox:

If you are allergic to amoxicillin, penicillin or any of the other ingredients of Glomox (listed in section 6). 

If you have ever had an allergic reaction to any antibiotic. This can include a skin rash or swelling of the face or throat.

Do not take Glomox if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Glomox.

Warnings and precautions

Talk to your doctor, or pharmacist before taking Glomox if you:

have glandular fever (fever, sore throat, swollen glands and extreme tiredness), lymphatic leukemia or HIV infection, since you may be more prone to developing a skin rash.

suffer from kidney problems, since you may need a lower dose.

are not urinating regularly.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Glomox.

Blood and urine tests If you are having:

Urine tests (glucose) or blood tests for liver function

Oestriol tests (used during pregnancy to check the baby is developing normally)

Tell your doctor or pharmacist that you are taking Glomox. This is because Glomox can affect the results of these tests.

Other medicines and Glomox

Please tell your doctor, or pharmacist if you are taking have recently taken or might take any other medicines. This is because Glomox can affect the way some other medicines work. Also some other medicines can affect the way Glomox works.

If you are taking allopurinol (used for gout) with Glomox, it may be more likely that you will have an allergic skin reaction.

If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Glomox.

If you are taking medicines to help stop blood clots (such as warfarin), you may need extra blood tests.

If you are taking other antibiotics (such as tetracycline) Glomox may be less effective.

If you are taking methotrexate (used for the treatment of cancer and severe psoriasis) Glomox may cause an increase in side effects.

Glomox with food and drink

Glomox may be taken before, during or after your meals.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Amoxicillin passes into breast milk, so tell your doctor if you are breast-feeding.

Ask your doctor for advice before taking any medicine.

Driving and using machines

Glomox can have side effects and the symptoms (such as allergic reactions, dizziness and convulsions) may make you unfit to drive. Do not drive or operate machinery unless you are feeling well.


Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Swallow with water without opening capsule.

Space the doses evenly during the day, at least 4 hours apart

The usual dose is:

Children weighing less than 40 kg who are able to swallow capsules

All doses are worked out depending on the child’s body weight in kilograms.

Your doctor will advise you how much Glomox you should give to your baby or child.

The usual dose is 40 mg to 90 mg for each kilogram of body weight a day given in two or three divided doses.

The maximum recommended dose is 100 mg for each kilogram of body weight a day.

Adults, elderly patients and children weighing 40 kg or more

The usual dose of Glomox is 250 mg to 500 mg three times a day or 750 mg to 1 g every 12 hours, depending on the severity and type of infection.

Severe infections: 750 mg to 1 g three times a day.

Urinary tract infection: 3 g twice daily for one day.

Lyme disease (an infection spread by parasites called ticks):

Isolated erythema migrans (early stage – red or pink circular rash): 4 g a day,

Systemic manifestations (late stage – for more serious symptoms or when the disease spreads around your body): up to 6 g a day.

Stomach ulcers: one 750 mg or one 1 g dose twice a day for 7 days with other antibiotics and medicines to treat stomach ulcers.

To prevent heart infection during surgery: the dose will vary according to the type of surgery. Other medicines may also be given at the same time. Your doctor, pharmacist or nurse can give you more details.

The maximum recommended dose is 6 g per day.

Patients with kidney problems: If you have kidney problems, the dose prescribed by your doctor may be lower than the usual dose.

If you take more of Glomox than you should: If you have taken too much Glomox, signs might be an upset stomach (feeling sick, being sick or diarrhoea) or crystals in the urine, which may be seen as cloudy urine, or problems urinating. Talk to your doctor as soon as possible. Take the medicine to show the doctor.

If you forget to take Glomox:

If you miss a dose, take it as soon as you remember and carry on as before. If it is almost time for your next dose, skip the missed dose and continue as usual.

 Do not take a double dose to make up for a forgotten dose.

How long should you take Glomox for?

Keep taking Glomox until the treatment is finished, even you feel better. You need every dose to help fight the infection. If some bacteria survive they can cause the infection to come back. Treatment should be continued for 2 to 3 days after symptoms have gone.

You should not need to take Glomox for more than 2 weeks. if you still feel unwell you should go back to see your doctor.

Thrush (a yeast infection of moist areas of the body which can cause soreness, itching and white discharge) may develop if Glomox is used for a long time. If this occurs tell your doctor. If you take Glomox for a long time, your doctor may perform additional tests to check your kidneys, liver and blood are working normally. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


Like all medicines, Glomox can cause side effects, although not everyone gets them. Stop taking Glomox and see a doctor straight away, if you notice any of the following serious side effects –you may need urgent medical treatment:

The following are very rare (may affect up to 1 in 10,000 people)

allergic reactions, the signs may include: skin itching or rash, swelling of the face, lips, tongue, body or breathing difficulties. These can be serious and occasionally deaths have occurred

rash or pinpoint flat red round spots under the skin surface or bruising of the skin.

This is due to an inflammation of blood vessel walls due to an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems.

a delayed allergic reaction can occur usually 7 to 12 days after having Glomox, some signs include: rashes, fever, joint pain and enlargement of lymph nodes especially under the arms.

a skin reaction known as ‘erythema multiforme’ where you may develop: itchy reddish purple patches on the skin especially on the palms of the hands or soles of the feet, ‘hive-like’ raised swollen areas on the skin, tender areas on the surfaces of the mouth, eyes and genitals. You may have a fever and be very tired

other severe skin reactions can include: changes in skin colour, bumps under the skin, blistering, pustules, peeling, redness, pain, itching, scaling. These may be associated with fever, headaches and body aches

Fever, chills, a sore throat or other signs of an infection, or if you bruise easily. These may be signs of a problem with your blood cells.

• flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))

the Jarisch-Herxheimer reaction which occurs during treatment with Glomox for Lyme disease and causes fever, chills, headache, muscle pain and skin rash.

inflammation of the large bowel (colon) with diarrhoea sometimes containing blood, pain and fever

serious liver side effects may occur. They are mainly associated with people having treatment over a long period, males and the elderly. You must tell your doctor urgently if you get:

   ▪ severe diarrhoea with bleeding 

▪ blisters, redness or bruising of the skin     

▪ darker urine or paler stools    

▪ yellowing of the skin or the whites of the eyes (jaundice). See also anaemia below which might result in jaundice.

These can happen when having the medicine or for up to several weeks after.

If any of the above happens stop taking the medicine and see your doctor straight away.

Sometimes you may get less severe skin reactions such as:

a mildly itchy rash (round, pink-red patches), ‘hive-like’ swollen areas on forearms, legs, palms, hands or feet. This is uncommon (may affect up to 1 in 100 people).

If you have any of these talk to your doctor as Glomox will need to be stopped.

The other possible side effects are:

Common (may affect up to 1 in 10 people)

skin rash  

feeling sick (nausea)       

diarrhoea.

Uncommon (may affect up to 1 in 100 people)

being sick (vomiting).

Very rare (may affect up to 1 in 10,000 people)

thrush (a yeast infection of the vagina, mouth or skin folds), you can get treatment for thrush from your doctor or pharmacist    kidney problems

fits (convulsions), seen in patients on high doses or with kidney problems

dizziness      hyperactivity 

crystals in the urine, which may be seen as cloudy urine, or difficulty or discomfort in passing urine. Make sure you drink plenty of fluids to reduce the chance of these symptoms

the tongue may change to yellow, brown or black and it may have a hairy appearance

an excessive breakdown of red blood cells causing a type of anaemia. Signs include: tiredness, headaches, shortness of breath, looking pale and yellowing of the skin and the whites of the eyes

low number of white blood cells   low number of cells involved with blood clotting

the blood may take longer to clot than it normally would. You may notice this if you have a nosebleed or cut yourself. If you gets any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet


Keep all medicines out of the sight and reach of children. Do not store above 30C. Store in a dry place. Protect from light. Do not use Glomox after the expiry date which is stated after ‘EXP’ on the blister and carton. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


The active substance is amoxicillin trihydrate.

Each Glomox 500mg capsule contains amoxicillin trihydrate BP equivalent to 500mg of amoxicillin. The other ingredients are sodium lauryl sulphate, purified Talc, magnesium stearate, iron oxide-red, iron oxide-yellow, titanium oxide and gelatin


Glomox 500mg capsules are hard gelatin size ‘0EL’ capsule with yellow colored body printed in black ‘GLOMOX 500’ and the cap is colored brown printed in white “globalpharma”. The capsule contains white to slightly yellow granular powder. Glomox 500 capsules are available in container packs of 20 capsules as (10’s blister X 2) and 100 capsules as (10’s blister X 10). (Not all pack sizes may be marketed).

Globalpharma Co. LLC, P. O. Box 72168, Dubai, UAE

Tel: +97148090900, Email:  info@globalpharma.ae


This leaflet was last revised in April 2019 (RLD 01/19)
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

ما هو جلوموكس: جلوموكس مضاد حيوي ، يحتوي على مادة فعالة تسمى أموكسيسيلّين وتنتمي إلى فئة من المضادات الحيوية تسمى "بنيسيلّين".

ما هي دواعي استخدام جلوموكس

جلوموكس يستخدم لعلاج العدوى التي تسببها البكتيريا في أجزاء مختلفة من الجسم .

جلوموكس يستخدم بالتزامن مع الأدوية الأخرى لعلاج قرحة المعدة

لا تتناول جلوموكس:

• إذا كنت تعاني من حساسية تجاه أموكسيسيلّين، البنسلّين أو أي من المكونات الأخرى في جلوموكس (المدرجة في القسم ٦)

• إذا عانيت من أي رد فعل تحسسي تجاه أي مضاد حيوي . ويشمل طفح جلدي أو تورم في الوجه أو الحلق.

لا تتناول جلوموكس إذا كان أي من المذكورة أعلاه ينطبق عليك . إذا كنت غير متأكد، إستشر طبيبك أو الصيدلي الخاص بك قبل أن تتناول جلوموكس.

التحذيرات و الاحتياطات

إستشر طبيبك أو الصيدلي الخاص بك قبل تناول جلوموكس إذا كنت :

• تعاني من الحمى الغدية ( حمى ، التهاب في الحلق، تورم الغدد ، تعب شديد ) ، سرطان الدم اللمفاوي

أو عدوى فيروس نقص المناعة البشرية ، حيث قد تكون أكثر عرضة للإصابة بطفح جلدي.

• تعاني من مشاكل في الكلى ، حيث قد تحتاج إلى جرعة أقل.

• تعاني من عدم انتظام في التبول .

إذا لم تكن متأكدا مما إذا كان أي من أعلاه ينطبق عليك ، إستشر طبيبك أو الصيدلي الخاص بك قبل أن تتناول جلوموكس .

إختبارات الدم والبول

إذا كنت تنوي إجراء:

• إختبارات البول ( جلوكوز) أو اختبارات فحص وظائف الكبد في الدم.

• إختبارات إسترايول ( إختبارات تجرى أثناء الحمل لفحص نمو الجنين )

أخبر طبيبك أو الصيدلي الخاص بك أنك تتناول جلوموكس ، لأن جلوموكس يؤثر على نتائج هذه الإختبارات .

الأدوية الأخرى و جلوموكس

يرجى إخبار طبيبك أو الصيدلي الخاص بك  إذا كنت تتناول ، أو تناولت مؤخرا أو قد تتناول أي أدوية أخرى . وذلك لأن جلوموكس يمكن أن يؤثر على الطريقة التي تعمل بها بعض الأدوية الأخرى.

أيضا بعض الأدوية الأخرى يمكن أن تؤثر على الطريقة التي يعمل بها جلوموكس.

• إذا كنت تتناول آلوبيورينول (يستخدم لمرض النقرس ) مع جلوموكس ، قد يكون لها رد فعل تحسسي في الجلد .

• إذا كنت تتناول بروبينسيد (يستخدم لمرض النقرس ) ، طبيبك قد يقرر تعديل الجرعة من جلوموكس .

• إذا كنت تتناول الأدوية للمساعدة في وقف جلطات الدم ( مثل وارفارين ) قد تكون هناك حاجة إلى مزيد من إختبارات الدم الإضافية .

• إذا كنت تتناول مضادات حيوية أخرى ( مثل تتراسيكلين ) جلوموكس قد يقلل من فعاليتها .

• إذا كنت تتناول ميثوتركسات ( يستخدم لعلاج السرطان وحالات الصدفية الشديدة )  جلوموكوس قد يزيد من تأثيراته الجانبية .

جلوموكس مع الطعام والشراب

يمكن أن تتناول جلوموكس قبل أو أثناء أو بعد وجبات الطعام الخاصة بك.

الحمل و الرضاعة الطبيعية

إذا كنت  حاملأً أو مرضع أو تعتقدين أنك قد تصبحين حاملا أو تنوين أن تكوني حاملا ، إستشيري طبيبك أو الصيدلي الخاص بك قبل تناول هذا الدواء.

يفرز أموكسيسيلّين في حليب الأم ، لذا أخبري طبيبك إذا كنت ترضعين طفلك.

إستشيري طبيبك قبل تناول أي دواء.

القيادة واستخدام الآلات

قد يكون لجلوموكس بعض التأثيرات الجانبية والأعراض (مثل تفاعلات الحساسية، الدوخة والتشنجات) قد تجعلك غير مؤهل للقيادة. لا تقد السيارة أو تستخدم الآلات حتى تشعر بأنك في حالٍ جيد .

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۳. كیفیة تناول جلوموكس

تناول هذا الدواء دائما كما أخبرك طبيبك أو الصيدلي الخاص بك بالضبط. إستشر طبيبك أو الصيدلي الخاص بك  إذا كنت غير متأكد.

•  ابتلع الكبسولات مع الماء بدون فتحها.

•  افصل بين الجرعات بالتساوي خلال اليوم  ، بما لا يقل عن اربعة ساعات بين الجرعات .

الجرعة المعتادة :

الأطفال الذين يقل وزنهم عن ٤٠ كجم القادرون على ابتلاع الكبسولات :

جميع الجرعات يتم تحديدها إستنادا إلى وزن جسم الطفل بالكيلوجرام.

• طبيبك سوف يخبرك بالجرعة المناسبة لطفلك.

• الجرعة المعتادة هي  ٤۰ ملجم إلى ٩۰ ملجم لكل كيلوجرام من وزن الجسم في اليوم ، تعطي مقسمة على جرعتين أو ثلاث جرعات.

• الحد الأقصى للجرعة الموصى بها هي ١٠٠ ملجم لكل كيلوجرام من وزن الجسم يوميا.

البالغين وكبار السن والأطفال الذين يبلغ وزنهم ٤٠ كجم أو أكثر :

الجرعة المعتادة من جلوموكس هي ۲٥٠ ملجم إلى ٥٠٠ ملجم  ثلاث مرات يوميا أو ٧٥٠ ملجم إلى

١ جرام كل ١۲ ساعة، وهذا يتوقف على شدة ونوع العدوى.

• العدوى الشديدة : ٧٥٠ ملجم إلى ١ جرام ثلاث مرات يوميا.

• عدوى المسالك البولية: ٣ جرامات مرتين يوميا لمدة يوم واحد.

• داء لايم (عدوى تنتشر عن طريق طفيليات تسمى القراد):

حمامي مهاجرة معزولة (المرحلة الأولى – طفح جلدي أحمر أو وردي دائري): ٤ جرامات يوميا .

مظاهر جهازية (مرحلة متأخرة - لأعراض أكثر خطورة أو عندما ينتشر المرض في جميع أنحاء الجسم) : حتى ٦ جرامات يوميا.

• قرحة المعدة: جرعة ٧٥٠ ملجم أو جرعة ١ جرام مرتين يوميا لمدة ٧ أيام مع المضادات الحيوية وغيرها من الأدوية الأخرى لعلاج قرحة المعدة.

• لمنع عدوى القلب أثناء الجراحة: الجرعة تختلف وفقا لنوع الجراحة.

يمكن إعطاء أدوية أخرى في نفس الوقت. طبيبك أو الصيدلي الخاص بك يمكن أن يعطيك المزيد من التفاصيل.

• الحد الأقصى للجرعة الموصى بها هي ٦ جرامات يوميا.

 المرضى الذين يعانون من مشاكل في الكلى

إذا كان لديك مشاكل في الكلى ، الجرعة التي سوف يحددها طبيبك قد تكون أقل من الجرعة المعتادة.

إذا تناولت جرعة زائدة من جلوموكس أكثر من التي عليك تناولها

إذا كنت قد تناولت جرعة زائدة من جلوموكس ، قد تظهر علامات اضطراب في المعدة ( الشعور بالغثيان ، التوعك أو الإسهال ) أو ظهور بلورات في البول والتي قد تظهر البول عكر أو مشاكل في التبول . إستشر طبيبك في أقرب وقت و خذ الدواء معك لعرضه على الطبيب .

إذا نسيت تناول جلوموكس

إذا فاتتك جرعة ، تناولها حالما تتذكرها ثم أكمل تناول الجرعات كالمعتاد.

إذا حان وقت الجرعة التالية قريبًا ، تخطي الجرعة الفائتة وأكمل كالمعتاد.

ما المدة التي يجب أن يتم تناول جلوموكس فيها ؟

• استمر في تناول جلوموكس حتى انتهاء العلاج ، حتى لو كنت تشعر بتحسن فإنك تحتاج لكل جرعة للمساعدة في مكافحة العدوى. إذا تمكنت بعض البكتيريا من النجاة فإنها يمكن أن تسبب عودة العدوى.

يجب أن يستمر العلاج لمدة ٢ إلى ٣ أيام بعد إختفاء الأعراض.

• يجب ألا تحتاج إلى تناول جلوموكس لأكثر من أسبوعين، وإذا كنت لا تزال تشعر بتوعك يجب أن تعود لرؤية الطبيب.

القلاع (عدوى الخميرة في المناطق الرطبة من الجسم التي يمكن أن تسبب قرحة ، حكة وإفرازات بيضاء) قد يزداد في حالة تناول جلوموكس لفترة طويلة. إذا كان هذا يحدث لك فأخبر طبيبك.

إذا كنت تتناول  جلوموكس لفترة طويلة، فإن طبيبك قد يجري اختبارات إضافية للتحقق من أن الكلى والكبد والدم لديك يعملون بشكل طبيعي. إذا كان لديك أي أسئلة أخرى عن استخدام هذا الدواء، إسأل طبيبك أو الصيدلي الخاص بك.

مثله مثل كافة الأدوية ، يمكن أن يسبب جلوموكس تأثيرات جانبية على الرَّغم من عدم حدوثها لدى الجميع.

توقف عن تناول جلوموكس واستشر طبيبك على الفور، إذا لاحظت أي من التأثيرات الجانبية الخطيرة التالية ، قد تحتاج إلى علاج طبي عاجل:

التأثيرات التالية نادرة جدا (قد تؤثر فيما يصل إلى شخص من أصل  ۱۰۰۰۰ شخص)

• تفاعلات الحساسية ، ويمكن أن تشمل علامات : حكة الجلد أو الطفح الجلدي، تورم في الوجه ، الشفتين ، اللسان ، الجسد أو صعوبة في التنفس . ويمكن أن تكون خطيرة وقد حدثت وفيات.

• طفح جلدي أو بقع حمراء مسطحة مستديرة محددة تحت سطح الجلد أو كدمات في الجلد .

ويرجع ذلك إلى التهاب جدران الأوعية الدموية هذا بسبب رد الفعل التحسسي. يمكن أن تترافق مع آلام المفاصل ( التهاب المفاصل ) و مشاكل في الكلى.

• يمكن أن يحدث رد فعل تحسسي متأخر عادة من ٧ إلى ۱٢ يوما  بعد تناول جلوموكس ، وتشمل بعض الأعراض : الطفح الجلدي، الحمى، آلام في المفاصل وتضخم العقد الليمفاوية وخصوصا تحت الاذرع.

• رد فعل جلدي معروف باسم ' حمامي عديدة الأشكال ' حيث قد يظهر عليك  : بقع أرجوانية حمراء مصحوبة بحكة على الجلد وخصوصا على راحتي اليدين أو باطن القدمين ، "مثل الشرى " تورم المناطق على الجلد ، والمناطق الحساسة على أسطح الفم والعينين و الأعضاء التناسلية . قد تعاني من الحمى و تكون متعبا جدا .

• تفاعلات جلدية أخرى شديدة  وتشمل : التغيرات في لون الجلد ، النتوءات تحت الجلد ، تقرحات ، بثور ، تقشير ، الاحمرار ، الألم، الحكة، و التقشير. هذه قد تترافق مع الحمى والصداع و آلام في الجسم.

• حمى ، قشعريرة ، التهاب الحلق أو غيرها من علامات وجود عدوى، أو سهولة الاصابة بكدمة. قد تكون هذه أعراض على وجود مشكلة في  خلايا الدم.

• أعراض شبيهة بأعراض الأنفلونزا مصحوبة بطفح جلدي، حُمى، تورم الغدد، ونتائج غير طبيعية في اختبارات الدَّم (بما في ذلك زيادة خلايا الدَّم البيضاء (كثرة خلايا اليُوزينِيَّات) وإنزيمات الكبد) (الطفح الجلدي التفاعلي الدوائي المصحوب بكثرة خلايا اليُوزينِيَّات والأعراض الجهازية DRESS).

• رد فعل ياريش هيكسهايمر الذي يحدث أثناء العلاج مع جلوموكس لداء لايم ويسبب حمى، قشعريرة، صداع، آلام في العضلات والطفح الجلدي.

• التهاب في الأمعاء الغليظة ( القولون ) مع إسهال أحيانا يحتوي على الدم ، والألم و الحمى.

• قد تحدث تأثيرات جانبية خطيرة في الكبد  . لأنها ترتبط مع أشخاص يتناولون العلاج على مدى فترة طويلة ، الذكور والمسنين. يجب عليك إخبار طبيبك على وجه السرعة إذا لاحظت:

▪ الإسهال الشديد مع نزيف

▪ بثور ، احمرار أو كدمات في الجلد

▪ بول داكن أو براز شاحب

▪ اصفرار الجلد أو بياض العينين ( اليرقان ) . انظر أدناه أيضا فقر الدم الذي قد يؤدي إلى اليرقان

 يمكن أن تحدث هذه التأثيرات عند تناول الدواء لمدة  طويلة تصل إلى عدة أسابيع.

إذا حدث أي من أعلاه يجب وقف تناول الدواء و مراجعة طبيبك على الفور.

في بعض الأحيان قد يحدث ردود فعل على الجلد أقل شدة مثل :

• طفح جلدي وحكة خفيفة ( بقع دائرية  وردية حمراء) ، ' مثل الشرى ' المناطق متورمة على الساعدين والساقين ، الكف ، اليدين أو القدمين . هذه غير شائعة (قد تؤثر فيما يصل إلى شخص من أصل  ۱۰۰ شخص ) .

إذا كان لديك أي من هذه التأثيرات استشر طبيبك كما يجب التوقف عن تناول جلوموكس  .

التأثيرات الجانبية الأخرى المحتملة هي :

شائعة  (قد تؤثر فيما يصل إلى شخص من أصل ۱۰ أشخاص)

• طفح جلدي

• شعور بالتوعك ( الغثيان )

• الإسهال.

غير شائعة (قد تؤثر فيما يصل إلى شخص من أصل  ۱۰۰ شخص)

• أن يكون متوعكا ( التقيؤ ) .

نادرة جدا (قد تؤثر فيما يصل إلى شخص من أصل  ۱۰۰۰۰ شخص)

• مرض القلاع ( عدوى الخميرة في المهبل ، الفم أو طيات الجلد) ، يمكنك الحصول على علاج لمرض القلاع من طبيبك أو الصيدلي الخاص بك

• مشاكل في الكلى

• نوبات (تشنجات ) ، تظهر على المرضى ذوي الجرعات العالية أو مع المرضى ذوي المشاكل في الكلى

• الدوخة                  

• فرط النشاط

• بلورات في البول ، والتي يمكن أن تظهر على هيئة  بول عكر، أو صعوبة أو عدم الراحة في التبول . تأكد من شربك الكثير من السوائل لتقليل فرصة ظهورهذه الأعراض

• تغير اللسان إلى اللون الأصفر ، البني أو الأسود ، وأنه قد يكون له مظهر شعر

• انهيار المفرط لخلايا الدم الحمراء مما يسبب شكلا من أشكال فقر الدم. وتشمل علامات : التعب ، الصداع ، ضيق في التنفس ، شحوب و اصفرار الجلد و بياض العينين.

• انخفاض عدد خلايا الدم البيضاء

• انخفاض عدد الخلايا المشاركة في تجلط الدم

• تجلط الدم قد يستغرق وقتا أطول من المعتاد. قد تلاحظ هذا إذا كنت تعاني من الرعاف أو جرحت نفسك .

إذا لاحظت أي من هذه التأثيرات الجانبية ، إستشر طبيبك أو الصيدلي الخاص بك  .

وهذا يشمل أي تأثيرات  جانبية المحتملة غير مدرجة في هذه النشرة.

تحفظ الأدوية بعيدا عن متناول الأطفال ونظرهم. يحفظ في درجة حرارة لا تزيد عن ٣٠ درجة مئوية في مكان جاف بعيدا عن الضوء. لا يستعمل جلوموكس بعد انقضاء تاريخ الصلاحية المدون على الشريط وعلى العبوة بعد كلمة EXP. لا ينبغي التخلص من الأدوية في المياه العادمة أو النفايات المنزلية . إسأل الصيدلي الخاص بك عن الطريقة المناسبة للتخلص من الأدوية التي لم تعد بحاجة إليها . فمن شأن هذه الإجراءات حماية البيئة.

المادة الفعالة هي أموكسيسيلّين ثلاثي الهيدرات . 

تحتوي كل  كبسولة جلوموكس ٥۰۰ ملجم على أموكسيسيلّين ثلاثي الهيدرات (طبقا لدستور الأدوية البريطاني) مكافئ لـ  ٥۰۰ ملجم أموكسيسيلّين.

المكونات الأخرى هي كبريتات لوريل الصوديوم، التلك المنقى، ستيرات المغنيسيوم، أكسيد الحديد الأحمر، أكسيد الحديد الأصفر، أكسيد التيتانيوم ، والجيلاتين

كبسولات جلوموكس ٥۰۰ ملجم هي كبسولات صلبة جيلاتينية حجمها ’ 0EL ‘مع قوام أصفر مطبوع عليها بالأسود ‘GLOMOX 500’ وقبعة بنية اللون مطبوع عليها باللون الأبيض “globalpharma” ، تحتوي الكبسولات على مسحوق محبب يميل  لونه من الأبيض إلى الأصفر الباهت.

 تتوفر كبسولات جلوموكس ٥۰۰ ملجم في عبوات تحتوي على ۲۰ كبسولة ( شريطان في كل منهما ۱۰ كبسولات ) أو ۱۰۰ كبسولة ( ۱۰ أشرطة في كل منها ۱۰ كبسولات).

( قد لا يتم تسويق جميع العبوات  ).

شركة جلوبال فارما ذ.م.م. ،  ص.ب. ۷۲۱٦٨ ، دبي ، الامارات العربية المتحدة .

هاتف: /٩٧١٤٨٠٩٠٩٠٠+/  ، بريد إلكتروني: info@globalpharma.ae

تم أخر تحديث لهذه النشرة في أبريل ۲۰۱٩ (RLD01/19)
 Read this leaflet carefully before you start using this product as it contains important information for you

Glomox 500 mg Capsules

Each Glomox 500mg capsule contains Amoxicillin trihydrate BP equivalent to 500mg of Amoxicillin. For the full list of excipients, see section 6.1.

Hard Capsules. Glomox 500mg capsules are hard gelatin size ‘0EL’ capsule with yellow colored body printed in black ‘GLOMOX 500’ and the cap is colored brown printed in white “globalpharma”. The capsule contains white to slightly yellow granular powder.

Glomox is indicated for the treatment of the following infections in adults and children (see section 4.2, 4.4 and 5.1).

• Acute bacterial sinusitis

• Acute streptococcal tonsillitis and pharyngitis

• Acute exacerbations of chronic bronchitis

• Community acquired pneumonia

• Acute otitis media

• Acute cystitis

• Acute pyelonephritis

• Asymptomatic Bacteriuria in pregnancy

• Typhoid and paratyphoid fevers

• Dental abscess with spreading cellulitis

• Prosthetic joint infections

• Helicobacter pylori eradication

• Lyme disease

Glomox is also indicated for the prophylaxis of endocarditis. Consideration should be given to official guidance on the appropriate use of antibacterial agents.


The dose of Glomox that is selected to treat an individual infection should take into account:

• The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4)

• The severity and the site of infection

• The age, weight and renal function of the patient; as shown below

The duration of therapy should be determined by the type of infection and the response of the patient, and should generally be as short as possible. Some infections require longer periods of treatment (see section 4.4 regarding prolonged therapy).

Adults and children ≥40 kg

Indication*

Dose*

Acute bacterial sinusitis

250mg to 500mg every 8 hours or 750mg to 1g every 12 hours

For severe infections 750mg to 1g every 8 hours

Acute cystitis may be treated with 3g twice daily for one day

Asymptomatic bacteriuria in pregnancy

Acute pyelonephritis

Dental abscess with spreading cellulitis

Acute cystitis

Acute otitis media

500mg every 8 hours, 750mg to 1g every 12 hours

For severe infections 750mg to 1g every 8 hours for 10 days

Acute streptococcal tonsillitis and pharyngitis

Acute exacerbations of chronic bronchitis

Community acquired pneumonia

500mg to 1g every 8 hours

Typhoid and paratyphoid fever

500mg to 2g every 8 hours

Prosthetic joint infections

500mg to 1g every 8 hours

Prophylaxis of endocarditis

2g orally, single dose 30 to 60 minutes before procedure

Helicobacter pylori eradication

750mg to 1g twice daily in combination with a proton pump inhibitor (e.g. omeprazole, lansoprazole) and another antibiotic (e.g. clarithromycin, metronidazole) for 7 days

Lyme disease (see section 4.4)

Early stage: 500mg to 1g every 8 hours up to a maximum of 4 g/day in divided doses for 14 days (10 to 21 days)

Late stage (systemic involvement): 500mg to 2g every 8 hours up to a maximum of 6 g/day in divided doses for 10 to 30 days

*Consideration should be given to the official treatment guidelines for each indication

Children <40 kg

Children may be treated with Glomox capsules or suspensions.

Glomox Suspension is recommended for children under six months of age.

Children weighing 40kg or more should be prescribed the adult dosage.

Recommended doses:

Indication+

Dose+

Acute bacterial sinusitis

20 to 90 mg/kg/day in divided doses*

Acute otitis media

Community acquired pneumonia

Acute cystitis

Acute pyelonephritis

Dental abscess with spreading cellulitis

Acute streptococcal tonsillitis and pharyngitis

40 to 90 mg/kg/day in divided doses*

Typhoid and paratyphoid fever

100 mg/kg/day in three divided doses

Prophylaxis of endocarditis

50 mg/kg orally, single dose 30 to 60 minutes before procedure

Lyme disease (see section 4.4)

Early stage: 25 to 50 mg/kg/day in three divided doses for 10 to 21 days

Late stage (systemic involvement): 100 mg/kg/day in three divided doses for 10 to 30 days

+ Consideration should be given to the official treatment guidelines for each indication.

*Twice daily dosing regimens should only be considered when the dose is in the upper range.

Elderly

No dose adjustment is considered necessary.

Renal impairment

GFR (ml/min)

Adults and children ≥ 40kg

Children < 40 kg#

greater than 30

No adjustment necessary

No adjustment necessary

10 to 30

Maximum 500mg twice daily

15 mg/kg given twice daily (maximum 500mg twice daily)

less than 10

Maximum 500 mg/day

15 mg/kg given as a single dose (maximum 500 mg)

# In the majority of cases, parenteral therapy is preferred

In patients receiving haemodialysis

Amoxicillin may be removed from the circulation by haemodialysis

 

Haemodialysis

Adults and children over 40kg

500mg every 24h

Prior to haemodialysis one additional dose of 500mg should be administered. In order to restore circulating blood levels, another dose of 500mg should be administered after haemodialysis

Children under 40kg

15 mg/kg/day given as a single daily dose (maximum 500mg).

Prior to haemodialysis one additional dose of 15 mg/kg should be administered. In order to restore circulating blood levels, another dose of 15 mg/kg should be administered after haemodialysis

In patients receiving peritoneal dialysis

Amoxicillin maximum 500mg/day

Hepatic impairment

Dose with caution and monitor hepatic function at regular intervals (see section 4.4 and 4.8).

Method of administration

Glomox is for oral use.

Absorption of Amoxicillin is impaired by food.

Therapy can be started parenterally according to the dosing recommendations of the intravenous formulation and continued with an oral preparation.

Swallow with water without opening capsule


Hypersensitivity to the active substance, to any of the penicillins or to any of the excipients listed in section 6.1. History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).

Hypersensitivity reactions

Before initiating therapy with Amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillin and cephalosporins or other beta-lactam agents (see sections 4.3 and 4.8).

Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals. If an allergic reaction occurs, Amoxicillin therapy must be discontinued and appropriate alternative therapy instituted.

Non-susceptible microorganisms

Amoxicillin is not suitable for the treatment of some types of infection unless the pathogen is already documented and known to be susceptible or there is a very high likelihood that the pathogen would be suitable for treatment with Amoxicillin (see section 5.1). This particularly applies when considering the treatment of patients with urinary tract infections and severe infections of the ear, nose and throat.

Convulsions

Convulsions may occur in patients with impaired renal function or in those receiving high doses or in patients with predisposing factors (e.g. history of seizures, treated epilepsy or meningeal disorders (see section 4.8).

Renal impairment

In patients with renal impairment, the dose should be adjusted according to the degree of impairment (see section 4.2).

Skin reactions

The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthemous pustulosis (AGEP, see section 4.8). This reaction requires Amoxicillin discontinuation and contra-indicates any subsequent administration.

Amoxicillin should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of Amoxicillin.

Patients with lymphatic leukaemia and possibly with HIV infection are particularly prone to developing erythematous rashes with Amoxicillin. Amoxicillin should be discontinued if a skin rash occurs.

Jarisch-Herxheimer reaction

The Jarisch-Herxheimer reaction has been seen following Amoxicillin treatment of Lyme disease (see section 4.8). It results directly from the bactericidal activity of Amoxicillin on the causative bacteria of Lyme disease, the spirochaete Borrelia burgdorferi. Patients should be reassured that this is a common and usually self-limiting consequence of antibiotic treatment of Lyme disease.

Overgrowth of non-susceptible microorganisms

Prolonged use of an anti-infective may result in the overgrowth of non-susceptible organisms (superinfection).

Antibiotic-associated colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life threatening (see section 4.8). Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during, or subsequent to, the administration of any antibiotics. Should antibiotic-associated colitis occur, Amoxicillin should immediately be discontinued, a physician consulted and an appropriate therapy initiated. Anti-peristaltic medicinal products are contra-indicated in this situation.

Prolonged therapy

Periodic assessment of organ system functions; including renal, hepatic and haematopoietic function is advisable during prolonged therapy. Elevated liver enzymes and changes in blood counts have been reported (see section 4.8)

 

Crystalluria

In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of Amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of Amoxicillin crystalluria. In patients with bladder catheters, a regular check of patency should be maintained (see section 4.8 and 4.9).

Anticoagulants

Prolongation of prothrombin time has been reported rarely in patients receiving Amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation (see section 4.5 and 4.8)

Interference with diagnostic tests

Elevated serum and urinary levels of Amoxicillin are likely to affect certain laboratory tests. Due to high urinary concentrations of Amoxicillin, false positive readings are common with chemical methods.

It is recommended that when testing for the presence of glucose in urine during Amoxicillin treatment, enzymatic glucose oxidase methods should be used.

The presence of Amoxicillin may distort assay results for oestriol in pregnant women


Oral anticoagulants

Oral anticoagulants and penicillin antibiotics have been widely used in practice without reports of interaction. However, in the literature there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of Amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of Amoxicillin (see sections 4.4 and 4.8).

Probenecid

Concomitant use of probenecid is not recommended. Probencid decreases the renal tubular secretion of amoxicilin. Concurrent use with Amoxicillin may result in increased and prolonged blood levels of Amoxicillin

Allopurinol

Concurrent administration of allopurinol during treatment with Amoxicillin can increase the likelihood of allergic skin reactions.

Tetracyclines

Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of Amoxicillin.

Methotrexate

Penicillins may reduce the excretion of methotrexate causing potential increase in toxicity


Pregnancy:

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Limited data on the use of Amoxicillin during pregnancy in humans do not indicate an increased risk of congenital malformations. Amoxicillin may be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.

Breastfeeding:

Amoxicillin is excreted into breast milk in small quantities with the possible risk of sensitisation. Consequently, diarrhoea and fungus infection of the mucous membranes are possible in the breast-fed infant, so that breast-feeding might have to be discontinued. Amoxicillin should only be used during breast-feeding after benefit/risk assessment by the physician in charge.

Fertility:

There are no data on the effects of Amoxicillin on fertility in humans. Reproductive studies in animals have shown no effects on fertility.


No studies on the effects on the ability to drive and use machines have been performed. However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines (see section 4.8).


The following convention has been utilised for the classification of undesirable effects:

Very common (≥1/10),

Common (≥1/100 to <1/10),

Uncommon (≥1/1000 to <1/100),

Rare (≥1/10,000 to <1/1000),

Very rare (<1/10,000),

Not known (cannot be estimated from the available data)

The majority of side effects listed below are not unique to Amoxicillin and may occur when using other penicillins.

The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and skin rash.

Unless otherwise stated, the frequency of adverse events has been derived from more than 30 years of post-marketing reports.

Infections and infestations

Very Rare:

Muco-cutaneous candidiasis

Blood and lymphatic system disorders

Very rare:

Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia.

Prolonged prothrombin and bleeding times (see section 4.4 - Special Warnings and Precautions for Use)

Immune system disorders

Very rare:

As with other antibiotics, severe allergic reactions, including angioneurotic oedema, anaphylaxis (see Section 4.4 - Special Warnings and Precautions for Use), serum sickness and hypersensitivity vasculitis

Not known:

Jarisch-Herxheimer reaction (see section 4.4)

If any hypersensitivity reaction occurs the treatment should be discontinued (See also Skin and subcutaneous tissue disorders).

Nervous system disorders

Very rare:

Hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.

Gastrointestinal disorders

Clinical Trial Data

*Common:

Diarrhoea and nausea.

*Uncommon:

Vomiting.

 

 

Post-marketing Data

Very rare:

Antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis see section 4.4).

Black hairy tongue

Hepato-biliary disorders

Very rare:

Hepatitis and cholestatic jaundice. A moderate rise in AST and/or ALT.

The significance of a rise in AST and/or ALT is unclear.

Skin and subcutaneous tissue disorders

Clinical Trial Data

*Common:

Skin rash

*Uncommon:

Urticaria and pruritus

Post-marketing Data

Very rare:

Skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, acute generalised exanthematous pustulosis (AGEP) (see section 4.4) and drug reaction with eosinophilia and systemic symptoms (DRESS).

(See also Immune system disorders).

Renal and urinary tract disorders

Very rare:

Interstitial nephritis.

Very rare:

Crystalluria (see Sections 4.4 and 4.9 Overdose).

*The incidence of these AEs was derived from clinical studies involving a total of approximately 6,000 adult and paediatric patients taking Amoxicillin.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at:

The National Pharmacovigilance Centre (NPC):

Fax: +966-11-205-7662

SFDA Call Center: 19999

E-mail: npc.drug@sfda.gov.sa

Website: https://ade.sfda.gov.sa


Symptoms and signs of overdose

Problems of overdosage with Amoxicillin are unlikely to occur. Gastrointestinal symptoms (such as nausea, vomiting and diarrhoea) and disturbances of the fluid and electrolyte balances may be evident. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4). Convulsions may occur in patients with impaired renal function or in those receiving high doses (see section 4.4 and 4.8).

Treatment of intoxication

Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance.

Amoxicillin can be removed from the circulation by haemodialysis


Pharmacotherapeutic group: penicillins with extended spectrum; ATC code: J01CA04

Mechanism of action

Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bactericidal peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death.

Amoxicillin is susceptible to degradation by beta-lactamases produced by resistant bacteria and therefore the spectrum of activity of Amoxicillin alone does not include organisms which produce these enzymes.

Pharmacokinetic/ pharmacodynamic relationship

The time above the minimum inhibitory concentration (T>MIC) is considered to be the major determinant of efficacy for Amoxicillin.

Mechanisms of resistance

The main mechanisms of resistance to Amoxicillin are:

• Inactivation by bacterial beta-lactamases

• Alteration of PBPs, which reduce the affinity of the antibacterial agent for the target.

Impermeability of bacteria or efflux pump mechanisms may cause or contribute to bacterial resistance, particularly in Gram-negative bacteria.

Breakpoints

MIC breakpoints for Amoxicillin are those of the European Committee on Antimicrobial Susceptibility Testing (EUCASAT) version 5.0.

Organism

MIC breakpoint (mg/L)

 

Susceptible ≤

Resistant >

Enterobacteriaceae

81

8

Staphylococcus spp.

Note2

Note2

Enterococcus spp.3

4

8

Streptococcus groups A, B, C and G

Note4

Note4

Streptococcus pneumoniae

Note5

Note5

Viridans group steprococci

0.5

2

Haemophilus influenza

26

26

Moraxella catarrhalis

Note7

Note7

Neisseria meningitides

0.125

1

Gram positive anaerobes except Clostridium difficile8

4

8

Gram negative anaerobes8

0.5

2

Helicobacter pylori

0.1259

0.1259

Pasteurella multocida

1

1

Non-species related breakpoints10

2

8

1Wild type enterobacteriaceae are categorised as susceptible to aminopenicillins. Some countries prefer to categorise wild type isolates of E. coli and P. mirabilis as intermediate. When this is the case, use the MIC breakpoint S≤ 0.5 mg/L

2Most staphylococci are penicillinase producers, which are resistant to Amoxicillin. Methicillin resistant isolates are, with few exceptions, resistant to all beta-lactam agents.

3Susceptibility to Amoxicillin can be inferred from ampicillin

4The susceptibility of streptococcus groups A, B, C and G to penicillins is inferred from the benzylpenicillin susceptibility

5Breakpoints relate only to non-meningitis isolates. For isolates categorised as intermediate to ampicillin avoid oral treatment with Amoxicillin. Susceptibility inferred from the MIC of ampicillin

6Breakpoints are based on intravenous administration. Beta-lactamase positive isolates should be reported resistant

7Beta lactamase producers should be reported resistant

8Susceptibility to Amoxicillin can be inferred from benzylpenicillin.

9The breakpoints are based on epidemiological cut-off values (ECOFFs), which distinguish wild-type isolates from those with reduced susceptibility.

10The non-species related breakpoints are based on doses of at least 0.5g x 3 or 4 doses daily (1.5 to 2 g/day).

The prevalence of resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.

In vitro susceptibility of micro-organisms to Amoxicillin

Commonly Susceptible Species

Gram-positive aerobes:

Enterococcus faecalis

Beta-hemolytic streptococci (Groups A, B, C and G )

Listeria monocytogenes

Species for which acquired resistance may be a problem

Gram-negative aerobes:

Escherichia coli

Haemophilus influenza

Helicobacter pylori

Proteus mirabilis

Salmonella typhi

Salmonella paratyphi

Pasteurella multocida

Gram-positive aerobes:

Coagulase negative staphylococcus

Staphylococcus aureus£

Streptococcus pneumoniae

Viridans group streptococcus

Gram-positive aerobes:

Clostridium spp.

Gram-negative aerobes:

Fusobactrium spp.

Other:

Borrelia burgdorferi

Inherently resistant organisms

Gram-positive aerobes:

Enterococcus faecium

Gram-negative aerobes:

Acinetobacter spp.

Enterobacter spp.

Klebsiella spp.

Pseudomonas spp.

Gram-negative anaerobes:

Bacteroids spp. (many strains of Bacteroides fragilis are resistant)

Others:

Chlamydia spp.

Mycoplasma spp.

Legionella spp.

† Natural intermediate susceptibility in the absence of acquired mechanism of resistance.

£ Almost all S.aureus are resistant to Amoxicillin due to production of penicillinase. In addition, all methicillin-resistant strains are resistant to Amoxicillin.


Absorption

Amoxicillin fully dissociates in aqueous solution at physiological pH. Amoxicillin is stable in the acid gastric secretion and is rapidly absorbed from the gastrointestinal tract after oral administration. Following oral administration, Amoxicillin is approximately 70% bioavailable. The time to peak plasma concentration (Tmax) is approximately one hour.

The pharmacokinetic results for a study, in which an Amoxicillin dose of 250 mg three times daily was administered in the fasting state to groups of healthy volunteers are presented below.

Cmax

Tmax*

AUC(0-24h)

T ½

(µg/ml)

(h)

(µg.h/ml)

(h)

3.3 ± 1.12

1.5 (1.0-2.0)

26.7 ± 4.56

1.36 ± 0.56

*Median (range)

In the range 250 to 3000 the bioavailability is linear in proportion to dose (measured as Cmax and AUC). The absorption is not influenced by simultaneous food intake.

Haemodialysis can be used for elimination of Amoxicillin.

Distribution

About 18% of total plasma Amoxicillin is bound to protein and the apparent volume of distribution is around 0.3 to 0.41/kg. Following intravenous administration, Amoxicillin has been found in gall bladder, abdominal tissue, skin, fat, muscle tissue, synovial and peritoneal fluids, bile and pus. Amoxicillin does not adequately distribute into the cerebrospinal fluid.

From animal studies there is no evidence for significant tissue retention of drug-derived material. Amoxicillin, like most penicillins, can be detected in breast milk (see section 4.6)

Amoxicillin has been shown to cross the placental barrier (see section 4.6).

Biotransformation

Amoxicillin is partly excreted in the urine as the inactive penicilloic acid in quantities equivalent to up to 10 to 25% of the initial dose.

Elimination

The major route of elimination for Amoxicillin is via the kidney.

Amoxicillin has a mean elimination half-life of approximately one hour and a mean total clearance of approximately 25 l/hour in healthy subjects. Approximately 60 to 70% of an orally administered dose is excreted unchanged in the urine during the first 6 hours after administration of a single 250mg or 500mg dose of Amoxicillin. Various studies have found the urinary excretion to be 50-85% for Amoxicillin over a 24 hour period.

Concomitant use of probenecid delays Amoxicillin excretion (see section 4.5)

Age

The elimination half-life of Amoxicillin is similar for children aged around 3 months to 2 years and older children and adults. For very young children (including preterm newborns) in the first week of life the interval of administration should not exceed twice daily administration due to immaturity of the renal pathway of elimination. In preterm infants with gestational age 26-33 weeks, the total body clearance after intravenous dosing of Amoxicillin, day 3 of life, ranged between 0.75 – 2 ml/min, very similar to the inuline clearance (GFR) in this population. Following oral administration, the absorption pattern and the bioavailability of Amoxicillin in small children may be different to that of adults. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Gender

Following oral administration of Amoxicillin to healthy males and female subjects, gender has no significant impact on the pharmacokinetics of Amoxicillin.

Renal impairment

The total serum clearance of Amoxicillin decreases proportionately with decreasing renal function (see section 4.2 and 4.4).

Hepatic impairment

Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.


There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.


Sodium Lauryl Sulphate

Purified Talc

Magnesium Stearate

Composition of the hard empty Gelatin Capsules:

Hard empty gelatin capsules, Bovine origin, size "0EL" capsules, with a yellow colored body printed in black " GLOMOX 500" and the cap is colored brown printed in white "globalpharma"

Brown cap composition:

Iron oxide-red (1 %) and titanium oxide (0.33 %)

Yellow body composition: Iron oxide-yellow (1 %) and titanium oxide (1.67%)

Gelatin BSE free Q.S. to 100%

Water: 14.5% ± 1.5%


Not applicable.


36 months

Do not store above 30◦ C. Store in a dry place. Protect from light.


Glomox 500 Capsules: Aluminium–aluminium Blister packs of 20 capsules (10’s Blister x 2)


Not applicable


Globalpharma Co. L.L.C., Dubai Investment Park, Jebel Ali, Dubai, U.A.E

10/05/2019
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